Device and method to prevent deep vein thrombosis

ABSTRACT

Deep vein thrombosis is a problem for persons who are substantially sedentary. This can be caused by an illness or trauma from an accident or in a sitting position for long period of time during long distant travel. The objective is to get motion, and an exertion into the person&#39;s legs, and particularly the feet. This is accomplished by a support that has at least one resilient unit, and preferably two such units. These units are on a support, which can be connected to the baseboard of a bed such as being an integral part of the baseboard or placed on the floor of any vehicles. The resilient units are connected and contain a fluid, which upon the application of pressure to one unit will allow fluid to flow from one resilient unit to another. The fluid preferably is heated and the pressure to be exerted to flow the fluid from one resilient unit to another can be regulated. Optimally a pump can be combined with the resilient units to pressurize the fluid and flow the fluid from one resilient unit to another to promote the person to move the fluid through the alternate pressing of the resilient units.

This invention relates to a device and method to prevent deep vein thrombosis in substantially sedentary person. More particularly this invention relates to a device that is combined with the baseboard of a bed and a method to use this device to prevent deep vein thrombosis (DVT).

For normal people this device can be made into portable devices for long distant travel (such as, airplanes, train, and all motor vehicles) to prevent DVT.

BACKGROUND OF THE INVENTION

Deep vein thrombosis can occur when a patient is confined to a bed for an extended period of time or people in long distant travel with limited use of the legs. Such a lack of activity, and particularly in the legs can lead to poor blood circulation in the legs and the potential for embolisms.

Deep vein thrombosis (DVT) is a common medical problem and particularly in traumatic brain injury, stroke, post operation, long term bed resting and rehabilitation patients. Current preventions can be classified to two categories: the first one is anticoagulant drugs which can reduce the risk of DVT and pulmonary embolisms, but this benefit is offset by a small and definite risk of serious hemorrhages. The second is physical methods (such as compression stockings applied to the legs) are not associated with any bleeding risk but there is insufficient evidence from randomized trials to support the routine use of physical methods for preventing DVT.

The multiple factors, including stasis, endothelial injury, and the status of the coagulation system, contribute to development of DVT. In the lower extremities, the stasis alone is usually the dominant factor initiating platelet aggregation and white blood cells to pass through the venous endothelial lining and damage it. Stasis is counteracted by calf and other muscular contraction. The inactivity and immobility of the muscular mass promote the pooling of blood in the calf and contribute to the development of DVT.

Post surgical patients and those with trauma, stroke and incapacitating malignancy, have restricted activity and often immobilized. This degree of immobilization leads to an increased incidence of thrombosis in the legs.

The devices described herein stimulate the ankle active range of motion and passive range of motion. As a result, calf muscular contraction is triggered, thereby preventing vein stasis, the primary factor that leads to the development of a clot. Furthermore, this device differs from current physical methods, such as pneumatic compression or compression stockings. The action of this device will improve blood circulation in the low extremities and promote the healing and recovering process. This is the result of active stimulation of the muscle mass rather than a passive stimulation. An active stimulation is more effective to prevent DVT.

BRIEF SUMMARY OF THE INVENTION

The invention is directed to a method and apparatus to assist in the prevention of DVT. The apparatus invention comprises a support with at least one resilient unit mounted on the support and a fluid in the resilient unit, and the resilient contacted by a person's foot, which compresses the resilient unit. In a further embodiment there are two resilient units with the resilient units being compressed alternatively by a person's feet, the fluid in the resilient unit flowing from one resilient unit to another upon the alternate application of pressure. A valve can be in a channel between the resilient units to regulate the pressure needed to flow the fluid from one resilient unit to another. Also associated with the channel can be a heater with sensors to maintain the fluid at a set temperature. The support for the resilient units can be the baseboard of the bed or the floor of any travel vehicles. The fluid can be a liquid or a gas. The choice of fluid and the pressure will to a degree be determined by the needs of the patient.

In an additional embodiment a pump can be included in the channel to assist the flow of fluid from one resilient unit to another resilient unit. This will be of use for persons early in their rehabilitation since it will move a person's feet and promote a person to put foot pressure against the resilient units. As a pressure is shared against a foot the patient will attempt to counteract this force. Such an additional embodiment can have a combined heater unit and can be connected to the baseboard of a bed or a separate portable unit.

In a usual treatment the person who is the patient or the passenger will in the first embodiment push a foot against one of the resilient units. Fluid will then flow from that resilient unit to the other resilient unit. Then the patient will push against the other resilient unit and fluid will flow to the first resilient unit. The person will continue the procedure for a set period of time as directed by the rehabilitation therapist.

In the case of a person in a sitting position such as during long distant travel, the resilient units are placed on the floor of any travel vehicle and the leg and foot movements remain the same.

In the use of the alternate embedment the patient will place his/her feet against the resilient units and turn on a pump that in a set cycle will flow fluid from one resilient unit to another resilient unit. This will put an alternating pressure against the person's feet and promote the application of pressure against the resilient units by the patient.

The result in the use of any of the embodiments is a substantial prevention of DVT in patients that have a substantial lack of mobility, and particularly a lack of mobility in the legs. This apparatus promotes leg activity and blood flow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a bed the resilient units where the support is the baseboard of a bed.

FIG. 2 shows a person in a bed with his/her feet alternately pressing against the resilient units.

FIG. 3 shows resilient units with a conduit for fluid between the resilient units.

FIG. 4 shows a resilient unit with an elevated reservoir.

FIG. 5 shows a range of motion of a person's foot against a resilient unit when compressing the resilient unit.

FIG. 6 shows a range of motion of a person's foot at rest against a resilient unit.

FIG. 7 shows a resilient unit with an integrated heater and pump.

DETAILED DESCRIPTION OF THE INVENTION

The invention will be described in more detail in the referred embodiments with reference to the views in the figures. The invention can be modified but such modifications will be within the present concept.

FIG. 1 shows a bed 10 with the resilient units 30 and 32 as a part of the bed baseboard 14. The bed has a headboard 12, mattress 24 and side rails 16, 18, 20 and 22. In FIG. 2 there is shown a patient 50 covered by blanket 52 in the bed 10. The patient's feet 54 and 56 alternately compress resilient units 30 and 32 respectively. When a resilient unit is compressed it will flow a fluid in that resilient unit to another resilient unit or to a reservoir.

When the device is used by a person in sitting position (figure not shown) the resilient units 30 and 32 can be place on the floor of any travel vehicles.

The flow of fluid from one resilient unit 30 to another resilient unit 32 is shown in FIG. 3. Here upon foot 56 compressing resilient unit 32, fluid will flow from resilient unit 32 through conduit 34 to resilient unit 30. Optionally in conduit 34 there can be a restricting valve or a pressure valve to adjust the pressure needed to flow the fluid from resilient unit 32 to resilient unit 30. A restricting valve will narrow channel 34 to reduce the rate of flow of fluid and cause the patient to exert a greater force on the resilient units. There also can be spring loaded pressure valve where a certain amount of energy must be applied to cause the fluid to flow from one resilient unit to another. Such valves are known and available.

FIG. 4 shows a simple resilient unit with an elevated reservoir 38. This reservoir is attached to resilient unit 36 by conduit 40. This conduit can contain a valve as discussed above with regard conduit 34. There can also be a thermostated heater to maintain the fluid in the resilient unit at a given temperature, usually body temperature.

FIGS. 5 and 6 show the range of motion of patient's foot 54 against resilient unit 30. This range of motion can be effective to prevent DVT. The range of motion can be changed by the use of different shaped resilient units.

FIG. 7 shows a resilient unit 46 that is connected to pump/heater 44 by means of conduit 42. In this embodiment such resilient unit will be pressurized alternatively along with another resilient unit as in FIGS. 2 and 3. This embodiment is useful when the patient does not as yet have sufficient strength to push on the resilient unit. By the resilient units being alternately pressurized the patient is prompted to push his/her foot against the resilient in response to the pressure. As to temperature it is preferred to maintain the temperature of the fluid at about body temperature of about 37° C.

The fluid can be essentially any liquid or gas. Liquid fluids are preferred. The viscosity of liquids can range from about 1 cp to about 150,000 cps. This will include water through gels.

The resilient units will be constructed of a rubber or other elastomer. The material should be quite resilient with the fluid and associated valving controlling the pressure that must be applied to the resilient unit. The thickness of the material should be sufficient to withstand daily use, but yet not prevent the ready deflection upon an applied force by a person's foot. Suitable elastomers include polymers and copolymers of ethylene, propylene, butane, butadiene, rubbers, foil, and polytetrafluoroethylene such as Teflon. These also can be in a laminate form. In addition, various foils can be used. 

1. A device to prevent deep vein thrombosis comprising a support, at least one resilient unit mounted on said support, a fluid in said resilient unit, and a means in association with and resilient unit to allow said fluid to flow from said resilient unit upon the application of a pressure on said resilient unit and return into said resilient unit upon the release of said pressure.
 2. A device as in claim 1 wherein there are at least two resilient units.
 3. A device as in claim 2 wherein the two resilient units are interconnected whereby said fluid can flow from a first resilient unit upon which pressure is being applied to a second resilient unit to which no pressure is being applied.
 4. A device as in claim 3 wherein there is a channel connecting the first resilient unit to the second resilient unit, a valve mechanism in said channel to assist in controlling the flow of said fluid.
 5. A device as in claim 4 wherein there is a heater to heat the fluid passing through said channel, at least one temperature sensor associated with said channel.
 6. A device as in claim 2 wherein there is a pump associated with said at least two resilient units, said pump flowing said fluid alternately from one resilient unit to another resilient unit.
 7. A device as in claim 1 wherein said support is a part of a bed or the floor of any travel vehicles and is located at the base of the bed or on the floor of any travel vehicles.
 8. A device as in claim 7 wherein there are at least two resilient units.
 9. A device as in claim 8 wherein the two resilient units are interconnected whereby said fluid can flow from a first resilient unit upon which pressure is being applied to a second resilient unit where no pressure is being applied.
 10. A device as in claim 9 wherein there is a channel connecting the first resilient unit to the second resilient unit, a valve mechanism in said channel to assist in controlling the flow of said fluid.
 11. A device as in claim 10 wherein there is a heater to heat the fluid passing through said channel, at least one temperature sensor associated with said channel.
 12. A device as in claim 8 wherein there is a pump associated with said at least two resilient units, said pump flowing said fluid alternately from one resilient unit to another resilient unit.
 13. A device as in claim 1 wherein said fluid is one of a liquid or a gas.
 14. A device as in claim 1 wherein the resilient unit is comprised of a flexible film which contains the fluid.
 15. A method of preventing deep vein thrombosis comprising providing placing at least one foot of a person to be treated in contact with at least one resilient unit, and having such person push said at least one foot against said at least one resilient unit with at least one foot.
 16. A method as in claim 15 wherein there are at least two resilient units.
 17. A method as in claim 16 wherein the two resilient units are interconnected whereby said fluid can flow from a first resilient unit upon which pressure is being applied to a second resilient unit where no pressure is being applied.
 18. A method as in claim 17 wherein there is a channel connecting the first resilient unit to the second resilient unit, a valve mechanism in said channel to assist in controlling the flow of said fluid.
 19. A method as in claim 18 wherein there is a heater to heat the fluid passing through said channel, at least one temperature sensor associated with said channel.
 20. A method as in claim 19 wherein there is a pump associated with said at least two resilient units, said pump flowing said fluid alternately from one resilient unit to another resilient unit.
 21. A method as in claim 15 where in said fluid is one of a liquid or a gas. 